The PAIN Study: Paracetamol, Aspirin and Ibuprofen New Tolerability Study: A Large-Scale, Randomised Clinical Trial Comparing the Tolerability of Aspirin, Ibuprofen and Paracetamol for Short-Term Analgesia
Authors: Moore N.1; Vanganse E.2; Leparc J-M.3; Wall R.4; Schneid H.5; Farhan M.4; Verrière F.5; Pelen F.5
Source: Clinical Drug Investigation, Volume 18, Number 2, August 1999 , pp. 89-98(10)
Publisher: Adis International
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Abstract:
Objective: This study aimed to compare directly aspirin (acetylsalicylic acid), ibuprofen and paracetamol (acetaminophen), first-line analgesics which are generally well tolerated, from a safety perspective in general practice.
Methods: This was a blinded, multicentre study in general practice of up to 7 days of aspirin, paracetamol (both up to 3g daily) or ibuprofen (up to 1.2g daily), administered for common painful conditions, using patient-generated data with physician assistance. The main outcome was the rate of significant adverse events (serious, severe or moderate events, events resulting in treatment discontinuation or a physician visit). Statistical analysis tested for equivalence between ibuprofen and paracetamol, and for difference with aspirin.
Results: 1108 general practitioners included 8677 adults (2900 aspirin, 2886 ibuprofen, 2888 paracetamol; three patients had no code label number). 8633 (99.5%) were evaluable, of whom 8233 (95%) adhered to the study protocol. The main indications were musculoskeletal or back pain (48%), sore throat, the common cold and flu (31%). Rates of significant adverse events were: aspirin 18.7%, ibuprofen 13.7%, and paracetamol 14.5%. Ibuprofen was statistically equivalent to paracetamol. Both were significantly better tolerated than aspirin (p < 0.001). Total gastrointestinal events (including dyspepsia) and abdominal pain were less frequent with ibuprofen (4 and 2.8%, respectively) than with paracetamol (5.3 and 3.9%) or aspirin (7.1 and 6.8%) [all p < 0.035]. There were six cases of non-serious gastrointestinal bleeding, four with paracetamol and two with aspirin, and one case of peptic ulcer with aspirin.
Conclusion: The overall tolerability of ibuprofen in this large-scale study was equivalent to that of paracetamol and better than that of aspirin. These findings could lead to a reassessment of the use of first-line analgesics for the short-term management of painful conditions in general practice, recommending ibuprofen first, because of the poor tolerability of aspirin and the potential risks of paracetamol overdose.
Keywords: Aspirin, therapeutic-use; Ibuprofen, therapeutic-use; Paracetamol, therapeutic-use; Musculoskeletal-pain, treatment; Pain, treatment; Randomised-controlled-trials; General-practice; Aspirin, adverse-reactions; Ibuprofen, adverse-reactions; Paracetamol, adverse-reactions; Analgesics, therapeutic-use; Nonsteroidal-antiinflammatories, therapeutic-use
Language: English
Document Type: Original article
Affiliations: 1: Department of Pharmacology, Université Victor Segalen, Hôpital Pellegrin, Bordeaux, France 2: Clinical Pharmacology Department, University of Lyon, Lyon, France 3: Service de Rhumatologie, Hôpital Ambroise Paré, Boulogne-Billancourt, France 4: Boots Healthcare International, Nottingham, England 5: Boots Healthcare, Courbevoie, France *
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